There’s a new coalition in town and it’s doing a good job of getting FDA’s attention. Here’s the brief back story: USP General Chapter <467> “Residual Solvents” took effect July 1, replacing General Chapter <467> “Organic Volatile Impurities.” In August, FDA issued a related draft guidance, Residual Solvents in Drug Products Marketed in the United States. Since that time, industry has experienced a a number of problems and confusion regarding the draft guidance and communications received from FDA’s Office of Generic Drugs, that seem to conflict with Chapter 467. In fact, there have been so many problems that these core industry groups–IPEC Americas, IPEC Europe, GPhA, CHPA, PhRMA, and SOCMA BPTF—decided to form the Coalition for Rational Implementation of USP General Chapter <467>. See their key concerns in this Oct. 6 letter published in the Federal Register.
 
Last week, the Coalition had a meeting at FDA with the Office of Pharmaceutical Science, headed by Helen Winkle. According to the minutes of the meeting, Winkle informed the group that “FDA was concerned about the issues that have been identified resulting from the implementation of the USP <467> General Chapter on Residual Solvents and that they wanted to listen to what the coalition had to say.”
 
The coalition went over the four key areas of concern, according to the meeting minutes. Number 1: Testing versus control—Industry, said the coalition, believes that the focus should be on the controls that are used as opposed to testing. Number 2: Identification of Class 3 solvents—the coalition feels that there is no justifiable reason why Class 3 solvents need to be identified providing that the levels are below 0.5%. Number 3: Use of Class 1 solvents—the coalition needs FDA to establish what types of information would be needed to warrant the continued use of Class 1 solvents in certain cases as long as the levels are below the limits listed in <467> for these solvents. And Number 4: Need for immediate relief while awaiting revised guidance—the coalition requested that FDA quickly develop a mechanism and a path forward to address the many pending ANDAs from both a short-term and a long-term perspective.
 
Although Winkle’s office did not establish a timeline for taking action after hearing the coalition’s suggestions, she did say the agency would try to address the issues within the next few days or weeks, according to the minutes.
 
Stay tuned to the websites of IPEC Americas, GPhA, or CHPA for updates.